ASCRIPTIN REGULAR STRENGTH BUFFERED ASPIRIN- aspirin tablet, film coated 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient(in each tablet)  

Buffered aspirin equal to 325 mg aspirin (NSAID)*

(buffered with aluminum hydroxide, calcium carbonate, and magnesium hydroxide)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

for the temporary relief of minor aches and pains associated with:
arthritis
headache
muscular aches
toothache
premenstrual & menstrual cramps
cold

Warnings

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include

hives
facial swelling
asthma (wheezing)
shock

 

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you:

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

 

Do not use

if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if you have

 stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
ulcers
bleeding problems
high blood pressure
heart or kidney disease
taken a diuretic
reached age 60 or older
asthma

Ask a doctor or pharmacist before use if you are taking:

any other drug containing an NSAID (prescription or nonprescription)
a blood thinning (anticoagulant) or steroid drug
a prescription drug for diabetes, gout, or arthritis
any other drug, or are under a doctor’s care for any serious condition

 

Stop use and ask a doctor if

an allergic reaction occurs. Seek medical help right away.
you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
stomach pain or upset gets worse or lasts
ringing in the ears or loss of hearing occurs
painful area is red or swollen
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
any new symptoms appear

If pregnant or breast-feeding, ask a health professional before use.

It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over: take 2  tablets every 4 hours while symptoms persist; not more than 12 tablets in 24 hours
children under 12 years: ask a doctor

Keep Out of Reach of Children

Other information

each tablet contains: calcium 70 mg, and magnesium 10 mg
store at controlled room temperature 200 -  250 C (680 -  770 F)
protect from moisture and excessive heat 

Inactive ingredients

Inactive ingredients carnauba wax, corn starch, croscarmellose sodium, FD&C red #40 lake, granular sugar, hypromellose, magnesium stearate, mannitol, methylparaben, microcrystalline cellulose, pregelatinized starch, propylene glycol, shellac, sodium saccharin, sorbitol, talc, titanium dioxide

Questions or comments?  

1-800-452-0051

Novartis Consumer Health, Inc.

200 Kimball Drive

Parsippany, NJ 07054-0622

Package Label

Ascriptin

Ascriptin

ASCRIPTIN  REGULAR STRENGTH BUFFERED ASPIRIN
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0067-0149
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM (UNII: I38ZP9992A)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
SUCROSE (UNII: C151H8M554)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MANNITOL (UNII: 3OWL53L36A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeROUNDSize11mm
FlavorImprint Code ASCRIPTIN
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0067-0149-101 in 1 CARTON09/24/200908/31/2014
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0067-0149-221 in 1 CARTON09/24/200908/31/2014
2225 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34309/24/200908/31/2014
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 1/2018
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC